Nolvadex (Tamoxifen)

Class of Drugs: Nonsteroidal antiestrogen

Manufacturer: AztraZeneca

Information on Patient Assistance program: Zeneca Pharmaceuticals Foundation Patient Assistance Program,  (800) 424-3727

Description: Nolvadex is dispensed in 10 and 20 mg white tablets. Each tablet is stamped with the name Nolvadex.

Ingredient: Tamoxifen citrate

Use:
Nolvadex is used in the treatment of metastatic breast cancer. Cancerous cells may be estrogen-dependent. Nolvadex binds to the estrogen receptors (ER) on the tumor cells depriving them of their supply of the hormone. Estrogen deprivation through aromatase inhibition is an effective and selective treatment for some postmenopausal patients with hormone-dependent (ER+) breast cancer. This drug does not seem to be as effective against ER negative tumors, although there was a 10% reduction in recurrence reported in one study. Maximum benefit seems to be reached after five years of medication. Prolonging the regimen longer than that span of time does not increase the benefits.

Warnings:

Grapefruit juice may significantly increase the pharmacologic activity of drugs metabolized by CYP 3A4, such as novadex. It is recommended that patients who are taking this medication avoid grapefruit juice to help prevent adverse effects.

Nolvadex is indicated only for high-risk patients. If you have a known allergic reaction to the drug or any of its ingredients, are taking any coumarin-type anticoagulant therapy or have a history of deep vein thrombosis (blood clots) or pulmonary emboli this drug should not be taken. There have been several incidences of pulmonary emboli, including three deaths.

Hypercalcemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with Nolvadex. If hypercalcemia becomes severe, Nolvadex should be discontinued.

There has been an increase of ovarian cysts, endometriosis, uterine fibroids and uterine and endometrial hyperplasia, polyps and cancer associated with taking this medication. Make sure to have routine gynecological visits. Let your doctor know immediately if you have any menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, or pelvic pain or pressure.

There is some debate over whether a very small percentage of people who take nolvadex develop liver cancer or have an increased risk for strokes. In some studies there were equal incidences of liver cancer and strokes in the control group and the group taking the medication. In other studies there were no reports of either liver cancer or stroke.

This drug has been associated with changes in liver enzyme levels, and more severe liver abnormalities including fatty liver, cholestasis, hepatitis and hepatic necrosis have been reported in rare cases. A few of these serious cases included fatalities, but again the relationship to the medication is not verified.

We're not done yet. The effects on the eye include corneal changes, decreased color vision perception, retinal vein thrombosis, and retinopathy. An increased incidence of cataracts and the need for cataract surgery has been reported.

Nolvadex may caused harm to the fetus if you become pregnant while on the medication. There are no good studies of nolvadex in pregnant women. There have been a small number of reports of vaginal bleeding, spontaneous abortions, birth defects, and fetal deaths. If this drug is used during pregnancy, or you becomes pregnant while taking it, or within approximately two months afterwards, there are potential risks to the fetus including the potential long term risk of a DES-like syndrome.

Side Effects:

There has been an increase of ovarian cysts, endometriosis, uterine fibroids and uterine and endometrial hyperplasia, polyps and cancer associated with taking this medication. Make sure to have routine gynecological visits. Let your doctor know immediately if you have any menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, or pelvic pain or pressure.

There is some debate over whether a very small percentage of people who take nolvadex develop liver cancer or have an increased risk for strokes. In some studies there were equal incidences of liver cancer and strokes in the control group and the group taking the medication. In other studies there were no reports of either liver cancer or stroke.

This drug has been associated with changes in liver enzyme levels, and more severe liver abnormalities including fatty liver, cholestasis, hepatitis and hepatic necrosis have been reported in rare cases. A few of these serious cases included fatalities, but again the relationship to the medication is not verified.

The effects on the eye include corneal changes, decreased color vision perception, retinal vein thrombosis, and retinopathy. An increased incidence of cataracts and the need for cataract surgery has been reported.

Other side effects include increased bone and tumor pain, which are sometimes associated with a good tumor response. They occur, if at all, shortly after starting the medication and generally disappear quickly. Analgesics (Tylenol) may be taken for the pain. The most frequent adverse reaction is hot flashes.

Other, less common reactions are hypercalcemia, peripheral edema, distaste for food, pruritus vulvae, depression, dizziness, light-headedness, headache, hair thinning and/or partial hair loss, and vaginal dryness, vaginal bleeding, vaginal discharge, menstrual irregularities, skin rash and headaches. Usually these are not severe enough to require dosage reduction or discontinuation of treatment. Very rare reports of erythema multiforme, Stevens-Johnson syndrome, bullous pemphigoid, and rare reports of hypersensitivity reactions including angioedema have been reported. Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Nolvadex.

Return to Drug Index

This information is intended as reference and not as medical advice. All treatment decisions should be made with your team of medical professionals and prescriptions must be given by your doctor. See TERMS AND CONDITIONS.